BCIwiki (bciwiki.com) — Neuromodulation for drug-resistant epilepsy has grown over two decades from vagus nerve stimulation alone into a field spanning responsive neurostimulation, deep brain stimulation, less-invasive cortical stimulation and sensing-enabled systems, according to Neurotech Reports. Medication remains first-line, but about one-third of people with epilepsy continue to have seizures.
Three implantable therapies hold FDA approval for epilepsy. LivaNova's VNS Therapy, approved in 1997, delivers programmed intermittent stimulation to the cervical vagus nerve; the AutoStim feature on SenTiva adds stimulation after a rapid heart-rate rise, which the report describes as physiology-triggered rather than EEG-based closed-loop therapy. Medtronic's anterior thalamic DBS was approved for epilepsy in 2018.
Only NeuroPace's RNS System reads brain signals directly. The skull-mounted neurostimulator connects to depth or cortical strip leads at the seizure focus, continuously senses electrocorticographic activity, detects patient-specific abnormal patterns and delivers brief pulses. Stored recordings build a long-term intracranial EEG record that physicians use to adjust programming and medication. The system first received FDA approval in 2013.
Most newer devices rest on company-reported early data. PRECISIS says its EASEE system, an open-loop array placed under the scalp outside the skull, is cleared to begin EASEE4US, a pivotal study of about 200 patients. Adraxe is developing a closed-loop system with no electrodes inside the brain, still in clinical validation. Synergia Medical says 5 patients have received its optically powered NAO.VNS implant in a first-in-human study. iVEAcare's system, per patent filings, includes sensing, detection and algorithm-based analysis; a feasibility study at two Australian centers plans to enroll 30 patients.
Meriem Bensalem-Owen, director of the University of Kentucky's comprehensive epilepsy program, named fully automated upload of intracranial recordings and rechargeable batteries as priorities for future systems. The report also notes an open-label study, NCT07145489, testing daily infrared-light treatment in people with epilepsy.